Subtle Medical Announces Strategic Partnerships with Siemens Healthineers and Bayer to Pioneer New AI-Driven Commercial Models in Medical Imaging

This year's medical imaging event RSNA has just opened, and Subtle Medical, a well-known AI medical imaging company, announced two significant commercial milestones:

On November 29, Subtle Medical successively announced partnerships with Siemens Healthineers and Bayer to explore two new commercial implementation models: pre-installing AI software on MRI machines and co-developing and selling AI-enhanced contrast agents.

It is reported that in this cooperation, Siemens will integrate Subtle Medical's SubtleMR™ related modules as pre-installed recommended software into its latest generation of MRI machines. SubtleMR™ will be seamlessly integrated into Siemens' image reconstruction pipeline, Open Recon, aiming to provide DL (deep learning) post-processing to denoise and enhance the clarity of almost all MRI sequences, achieving further acceleration.

At the same time, Bayer will collaborate with Subtle Medical to integrate its SubtleGAD product with Bayer's globally leading contrast agent products, enabling safer, higher-quality, and more efficient enhanced MRI scans.

The commercial implementation of AI medical imaging companies has long been a question under scrutiny. Subtle Medical has widely carried out clinical and commercial deployments in the largest hospitals and imaging centers globally. By revolutionizing the existing market with AI technology, it helps hospitals and imaging centers reduce costs and improve efficiency. It has successfully implemented the clinical application and commercial transformation of AI software SaaS, achieving rapid growth in high-gross-margin SaaS revenue.

Subtle Medical’s recent announcement of Siemens Healthineers’ pre-installed AI-empowered MRI machines and the collaboration with Bayer to advance AI-driven pharmaceutical applications, together with the previously established clinical AI SaaS services, form the "three pillars" of AI imaging technology commercialization.

From the server side, to the device side and the pharmaceuticals side, the various business models that Subtle Medical has implemented are jointly driving the realization of the commercial landing vision for AI medical imaging enterprises.

Subtle Medical was founded at the end of 2017. It accelerates medical imaging such as MRI and PET through proprietary AI technology, enhances imaging and contrast agent performance, reduces radiation exposure and contrast agent dosage. Its products, SubtleMR and SubtlePET, are the first AI-powered medical imaging acceleration products in the MRI and PET fields respectively to receive approval from the U.S. FDA. Subtle Medical is now a global leader in the AI medical imaging industry.

Subtle Medical RSNA2021 Conference Booth

Innovative Commercial Implementation Model

"Who will pay" has always been a difficulty in the implementation of AI medical applications. Previously, the cooperation between AI medical imaging companies and medical institutions was mostly focused on high-quality data resources, with limited commercial implementation methods.

Since the beginning of this year, Subtle Medical has made remarkable progress in clinical software and SaaS sales, entering hundreds of hospitals and imaging centers worldwide, including the largest third-party imaging alliances in China, the U.S., Europe, and South America. At the same time, it has successfully implemented multiple business models, collaborating with industry giants such as Siemens Healthineers and Bayer AG on development and productization, jointly transforming multibillion-dollar markets for MR equipment and contrast agents. The scale of the anticipated cooperative products is expected to lead to new markets worth hundreds of millions of dollars in the coming years.

The commercial progress of Subtle Medical holds significant reference value for the AI imaging industry and its future collaborations with medical institutions and pharmaceutical companies.

Siemens is one of the three giants in the global MRI machine market, with annual medical device sales reaching 10 billion US dollars. According to data released by the third-party platform Yizhaocai, in China, Siemens occupies nearly 30% of the MRI machine market, ranking first in market share; in the global approximately 6 billion US dollar overall new MR equipment sales market, Siemens also occupies nearly 30%.

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In this collaboration, Subtle Medical becomes the first partner selected by Siemens Healthineers to empower its new platform, Open Recon. This also means that SubtleMR will be available as one of the recommended product accessories for purchase on Siemens' mass-produced MRI machines. The Open Recon interface is designed to enable third-party image reconstruction and post-processing solutions to be directly integrated into the reconstruction pipeline. As a result, users save data transmission time, and in terms of processing, they can access both raw machine data and image data, achieving high security and full closed-loop service.

At the same time, SubtleMR also uses this interface to achieve more convenient and faster raw data reading, providing a new data stream resource for further accelerating imaging and improving image quality, paving the way for subsequent products.

SubtleMR™ accelerates MRI examinations and enhances image quality and resolution through deep learning technology. Currently, it can achieve 4-10 times acceleration of MRI and PET imaging processes using AI technology. In practical applications, MRI can be further accelerated by 2-4 times on top of existing software and hardware acceleration. Recently, multi-center validation papers published in journals such as AJNR have confirmed that its imaging enhancement can deliver higher image quality than 3 times acceleration, enabling fast and high-precision MR brain region quantification analysis for neurological diseases like Alzheimer's. Recently, SubtleMR 2.0 has received FDA approval again, covering all parts of the human body.

                                                                                                                                           Comparison of SubtleMR Enhanced Before and After Images

"The focus of Siemens Healthineers' imaging business is continuous innovation in core operations, expansion of imaging products, increased market share, and advancement of the company’s digital transformation. Seamless integration of AI with Siemens equipment can further enhance imaging quality and efficiency, offering significant clinical value. It can help patients receive accurate and timely diagnoses and effective treatment," said Gong Enhao.

Bayer AG is a globally renowned pharmaceutical group with annual revenues exceeding 40 billion USD. In the global contrast agent market, which is approximately 7 billion USD, Bayer ranks first and continuously develops innovative products. For instance, in 2018, Bayer launched the new Medrad injection system, and in 2019, it received FDA approval in the United States for Gadavist as the first FDA-approved MRI contrast agent for cardiac use and the first large-package agent that can be used for multiple patients.

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In the business field, Bayer AG is known for optimizing image quality and imaging workflow efficiency, which aligns well with Subtle Medical's product line.

The cooperation between Bayer and Subtle Medical this time covers another product, SubtleGAD. Globally, more than 30 million people receive injections of gadolinium-based MRI contrast agents annually. SubtleGAD focuses on improving the quality of MRI detection while reducing potential risks and issues such as gadolinium deposition during MRI scans. In April this year, the international patent submitted by the Subtle Medical team in 2017 entered the multi-country approval process and was granted a patent by the United States Patent and Trademark Office (USPTO).

Subtle Medical's team has collaborated with several globally leading medical institutions, such as Stanford, UCSF, and Tiantan Hospital, to conduct clinical validation of SubtleGAD. Research findings have confirmed that by using SubtleGAD's enhancement, only 10% of the standard Gadolinium-based contrast agent dose is required to achieve equivalent or even better image diagnostic quality compared to a full-dose MRI scan.

"At Bayer, we are always striving to advance the development of medical knowledge and provide doctors and patients with the best treatment and diagnostic options," said Professor Olaf Weber, Head of Radiology Research and Development at Bayer. "We are excited to collaborate with Subtle Medical, leveraging the power of artificial intelligence with the ultimate goal of equipping doctors with the means to achieve optimal patient diagnosis."

Previously, Subtle Medical's main business model was to empower existing medical imaging machines. Due to its neutral characteristics, it is compatible with manufacturers and analysis software of various brands, and can be seamlessly integrated into various OEM scanning machines and PACS systems, enabling large-scale "virtual upgrades" and standardization of existing testing machines in medical institutions.

Exploring new business models with industry-leading enterprises signifies that Subtle Medical has officially entered the next phase: its technology and products are widely recognized within the industry. Together with partners, Subtle Medical aims to capture future markets, including the rapidly growing, massive MRI equipment market and the billions of dollars contrast agent market.

AI Empowerment Drives Digital Transformation in the Medical Imaging Industry

Siemens and Bayer are leading enterprises in traditional fields. Their cooperation with Subtle Medical reflects the urgent need for transformation of traditional medical industry leaders and the direction of new business expansion.

Taking the MRI market as an example, according to the latest 2021 report by Research and Markets, the importance of MRI technology in modern medical diagnostics is increasing, and its use is expected to be more widely applied clinically on a global scale. The use of MRI in Alzheimer's disease, cancer screening, cardiovascular, abdominal, and breast imaging is projected to increase multiple times during the forecast period, driving the continuous growth of the global MRI market. Greater demand means that medical institutions will need to adopt more new technologies and optimize processes to reduce scan times, increase throughput, and improve the experience for both patients and staff.

Globally, the contrast agent market is approximately USD 7 billion. According to Marketsandmarkets forecasts, from 2021 to 2025, this market will continue to grow at a compound annual growth rate of over 7%. Driving factors include the increasing prevalence of cancer and cardiovascular diseases; numerous contrast agent approvals; and growing investments and funding support from governments and institutions.

However, the high cost of contrast injectors, consumables, and accessories has, to a certain extent, restrained market growth. Safety concerns associated with contrast agents are also driving a major trend in the industry toward safer, lower-dose, and higher-quality solutions.

AI technology is precisely the solution to help reduce costs and expand the application of medical imaging. By optimizing imaging techniques through deep learning, it greatly enhances the quality and speed of image acquisition. ModorIntelligence predicts that the compound annual growth rate (CAGR) of the AI market in the medical imaging field is expected to be 30.4% during the forecast period from 2021 to 2026.

"By partnering with Subtle Medical, these traditional medical institutions can enter new markets, integrate AI technology into new products and business models, provide higher-quality medical imaging services, and reduce costs; we can also leverage multi-party cooperation for win-win outcomes and capture the market. This is expected to drive new revenue growth of tens of millions of dollars annually for the company after commercialization," said Dr. Greg Zhang, founder and CEO of Subtle Medical.

Apart from Siemens Healthineers and Bayer, Subtle Medical has been continuously empowering internationally renowned medical imaging institutions and healthcare organizations, with an influence spanning mainstream markets in China, the U.S., and Europe. Previously, it also successively enteredPhilipsChina Cooperation Platform, and discussions with GE Healthcare, Neusoft Medical, etc.

It is reported that the AI products of Subtle Medical have been deployed across hundreds of imaging service alliances and enterprises globally. Recently, Subtle Medical announced commercial agreements with RadNet, the largest imaging center alliance in the United States, and Vizient and Capstone, the largest medical procurement alliances in the U.S. Previously, Subtle Medical had already reached commercial agreements with Affidea, the largest third-party testing institution in Europe, and DASA, the largest medical examination institution in South America.

In addition, its international clinical partners also includeStanford UniversitySchool of Medicine (Stanford Medical Center), University of California, San Francisco (UCSF), MDAndersonMD Anderson, Hoag Hospital, Mount Sinai, SickKids (The Hospital for Sick Children affiliated with the University of Toronto), Mayo Clinic, and Middlesex Hospital under the Mayo Clinic alliance, etc.

Relevant papers have been published in top journals such as Nature sub-journals and Radiology AI. These clinical and industry collaborations not only verify their technical advantages but also demonstrate the rich clinical scenarios of their AI technology applications in clinical imaging.

On the other hand, the Chinese market is currently the second largest market for MRI, and also one of the strongest drivers of market growth. The ownership rate of MRI machines in China is only 1/7 of that in the U.S. market, indicating huge market potential. In China, domestic medical products are continuously making breakthroughs on the technical front, achieving faster local real-time AI processing and analysis, ensuring real-time imaging data processing and medical data security.

As one of the most well-known upstream technology providers in both the Chinese and American markets, Subtle Medical will play a crucial role as a bridge and provide technical empowerment during the growth of the MRI market in China.

Technology-Driven, Global Expansion

It is not difficult to see that the core reason for Subtle Medical becoming the first pre-installed software partner of Siemens Healthineers and collaborating with Bayer, a leading company in the pharmaceutical field, lies in the advanced and unique nature of its technology.

In the field of AI medical imaging, most AI companies focus on areas such as image analysis. Subtle Medical is one of the few AI enterprises targeting the upstream sector of AI medical imaging. By utilizing AI technology for image enhancement at the scanning stage, the company has successfully ensured minimal disruption to existing medical workflows while accelerating the implementation of its technology through this unique approach.

In addition to SubtleMR and SubtleGAD, since its establishment, Subtle Medical has also developed the SubtlePET product, which received FDA approval as early as 2019. Its 2.0 version obtained the European CE Mark and U.S. FDA approval this year. The coverage of the new generation technology has further expanded, encompassing radiopharmaceuticals for PSMA (prostate) cancer, Amyloid beta radionuclides for Alzheimer's disease, and various other rapidly growing cutting-edge industry applications.

                                                                                                                                           Comparison of SubtlePET Images Before and After Enhancement

In addition, Subtle Medical has multiple clinical and pharmaceutical-related imaging AI product pipelines that are also accelerating in research and clinical validation. The multi-dimensional product matrix allows Subtle Medical to stand out in the upstream enhancement field of imaging AI. In 2020, Subtle Medical was selected for CB Insights' Global AI 100. In October 2021, Yicai Healthcare officially released the "Top 100 Digital Healthcare Companies in China," with Subtle Medical being named one of the top 20 medical AI companies in China.

The technology of Subtle Medical originated from Stanford University. Its founder, Dr. Enho Gong, graduated from Tsinghua University and Stanford University successively. After obtaining his doctorate, he founded Subtle Medical, Inc. in the United States, as well as several other enterprises, including Beijing Subtle Technology Co., Ltd., the only authorized subsidiary in China. He has been honored with Forbes 30-under-30, RSNA Best Research, and other accolades.

Over the years, Subtle Medical has continuously invested substantial resources in technology research and development. The team includes scholars and scientists from top universities such as Stanford, Berkeley, Harvard, MIT, and CMU. It currently holds dozens of international patents, and its technologies and application effects have been certified by multiple peer-reviewed academic journals.

Multiple academic papers related to SubtleMR have been published in top clinical journals such as AJNR (AMERICAN JOURNAL OF NEURORADIOLOGY), FRONTIERS IN NEUROLOGY, JACR (Journal of the American College of Radiology), and more. It has also been nominated for the Aunt-Minnie Annual Paper Award by authoritative medical imaging media.

In August this year, a paper completed through the collaboration of Subtle Medical with Stanford University School of Medicine, University of Southern California School of Medicine, and other globally leading clinical imaging research institutions was published in the Nature sub-journal NPJ Digital Medicine (Impact Factor 11.6).

Academic papers on clinical validation of SubtleGAD, conducted both in China and internationally in collaboration with institutions such as Stanford University and Tiantan Hospital, have been published in the most important journals in the field of magnetic resonance, including MRM (Magnetic Resonance in Medicine) and European Radiology.

Since its establishment, Subtle Medical has raised more than 20 million US dollars in multiple rounds of financing, with the Series A round led byHerbal CapitalLeading investment,Datai Capital、Legend StarFollow-on investors, early investors Fusion Fund, Foothill Ventures, Data Collective, Breyer Capital, BV Baidu Ventures, etc., oversubscribed.